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A Replication-Defective Herpes Simplex Virus (HSV)-2 Vaccine, HSV529, is Safe and Well-Tolerated in Adults with or without HSV Infection and Induces Significant HSV-2-Specific Antibody Responses in HSV Seronegative Individuals

Abstract Background We conducted a phase 1, randomized, double-blind, placebo-controlled trial of a replication-defective HSV-2 vaccine, HSV529 (deleted for UL5 and UL29), in 60 healthy adults aged 18 to 40 years. Methods Subjects were enrolled in groups of 20 from 3 serogroups: HSV1+ or 
-/HSV2+ (g...

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Published in:Open forum infectious diseases 2017-10, Vol.4 (suppl_1), p.S415-S416
Main Authors: Dropulic, Lesia, Wang, Kening, Oestreich, Makinna, Pietz, Harlan, Garabedian, Doreen, Jegaskanda, Sinthujan, Dowdell, Kennichi, Nguyen, Hanh, Laing, Kerry, Koelle, David, Azose, Aaron, Hunsberger, Sally, Lumbard, Keith, Chen, Aiying, Chang, Lee-Jah, Phogat, Sanjay, Cohen, Jeffrey
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container_issue suppl_1
container_start_page S415
container_title Open forum infectious diseases
container_volume 4
creator Dropulic, Lesia
Wang, Kening
Oestreich, Makinna
Pietz, Harlan
Garabedian, Doreen
Jegaskanda, Sinthujan
Dowdell, Kennichi
Nguyen, Hanh
Laing, Kerry
Koelle, David
Azose, Aaron
Hunsberger, Sally
Lumbard, Keith
Chen, Aiying
Chang, Lee-Jah
Phogat, Sanjay
Cohen, Jeffrey
description Abstract Background We conducted a phase 1, randomized, double-blind, placebo-controlled trial of a replication-defective HSV-2 vaccine, HSV529 (deleted for UL5 and UL29), in 60 healthy adults aged 18 to 40 years. Methods Subjects were enrolled in groups of 20 from 3 serogroups: HSV1+ or 
-/HSV2+ (group 1), HSV1+/HSV2– (group 2), and HSV1-/HSV2– (group 3). At months 0, 1, and 6, 15 subjects in each group received HSV529 intramuscularly and 5 subjects received placebo. The primary endpoint was the frequency of solicited injection site and systemic reactions from day 0 to 7 after each vaccination and unsolicited adverse events up to 6 months after the last dose. Results 89% of vaccine recipients experienced a mild to moderate solicited injection site reaction vs. 47% of placebo recipients (P = 0.006, 95% CI 0.129, 0.676) that did not preclude additional doses. 64% of vaccine recipients experienced solicited systemic reactions vs. 53% of placebo recipients (P = 0.44, 95% CI -0.179, 0.402). Two serious adverse events occurred in 2 participants and were assessed as unrelated to HSV529 administration. Serum neutralizing antibody titers significantly increased from baseline after 3 doses of HSV529 compared with placebo in group 3 only (P < 0.001). This increase persisted up to 6 months after the third dose of vaccine (P < 0.001). Serum and vaginal antibodies to HSV2 glycoprotein D (gD) also significantly increased after 3 doses of vaccine in group 3 subjects (P < 0.001 and P = 0.012, respectively). The mean vaginal gD titer after 3 doses was about one-third of the mean serum gD titer. In addition, the vaccine induced significant levels of HSV2-specific antibody dependent cellular cytotoxicity (ADCC) after 3 doses in group 3 subjects compared with placebo (P < 0.001). Vaccine-induced CD4 T-cell responses were detected in 46%, 27%, and 36% of subjects in groups 1, 2, and 3, respectively, one month after the third dose of vaccine. CD8 T-cell responses were detected in 8%, 18%, and 14% of subjects in groups 1, 2, and 3, respectively, at the same time point. Conclusion The HSV529 vaccine was safe, well-tolerated, and immunogenic, eliciting significant neutralizing, gD, and ADCC-mediating antibodies, and modest cellular immune responses in HSV seronegative individuals. NCT01915212 Disclosures L. Dropulic, sanofi pasteur: Collaborator, Research support; K. Wang, sanofi pasteur: Collaborator, Research support; M. Oestreich, sanofi pasteur: Collaborator, Research support;
doi_str_mv 10.1093/ofid/ofx163.1041
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-/HSV2+ (group 1), HSV1+/HSV2– (group 2), and HSV1-/HSV2– (group 3). At months 0, 1, and 6, 15 subjects in each group received HSV529 intramuscularly and 5 subjects received placebo. The primary endpoint was the frequency of solicited injection site and systemic reactions from day 0 to 7 after each vaccination and unsolicited adverse events up to 6 months after the last dose. Results 89% of vaccine recipients experienced a mild to moderate solicited injection site reaction vs. 47% of placebo recipients (P = 0.006, 95% CI 0.129, 0.676) that did not preclude additional doses. 64% of vaccine recipients experienced solicited systemic reactions vs. 53% of placebo recipients (P = 0.44, 95% CI -0.179, 0.402). Two serious adverse events occurred in 2 participants and were assessed as unrelated to HSV529 administration. Serum neutralizing antibody titers significantly increased from baseline after 3 doses of HSV529 compared with placebo in group 3 only (P &lt; 0.001). This increase persisted up to 6 months after the third dose of vaccine (P &lt; 0.001). Serum and vaginal antibodies to HSV2 glycoprotein D (gD) also significantly increased after 3 doses of vaccine in group 3 subjects (P &lt; 0.001 and P = 0.012, respectively). The mean vaginal gD titer after 3 doses was about one-third of the mean serum gD titer. In addition, the vaccine induced significant levels of HSV2-specific antibody dependent cellular cytotoxicity (ADCC) after 3 doses in group 3 subjects compared with placebo (P &lt; 0.001). Vaccine-induced CD4 T-cell responses were detected in 46%, 27%, and 36% of subjects in groups 1, 2, and 3, respectively, one month after the third dose of vaccine. CD8 T-cell responses were detected in 8%, 18%, and 14% of subjects in groups 1, 2, and 3, respectively, at the same time point. Conclusion The HSV529 vaccine was safe, well-tolerated, and immunogenic, eliciting significant neutralizing, gD, and ADCC-mediating antibodies, and modest cellular immune responses in HSV seronegative individuals. NCT01915212 Disclosures L. Dropulic, sanofi pasteur: Collaborator, Research support; K. Wang, sanofi pasteur: Collaborator, Research support; M. Oestreich, sanofi pasteur: Collaborator, Research support; H. Pietz, sanofi pasteur: Collaborator, Research support; D. Garabedian, sanofi pasteur: Collaborator, Research support; K. Dowdell, sanofi pasteur: Collaborator, Research support; H. Nguyen, sanofi pasteur: Collaborator, Research support; K. Laing, sanofi pasteur: Research Contractor, payment for conducting T cell assays; D. Koelle, sanofi pasteur: Research Contractor, payment for conducting T cell assays; A. Azose, sanofi pasteur: Research Contractor, Payment for conducting T cell assays; A. Chen, sanofi pasteur: Employee, Salary; L. J. Chang, sanofi pasteur: Employee, Salary; S. Phogat, sanofi pasteur: Employee, Salary</description><identifier>ISSN: 2328-8957</identifier><identifier>EISSN: 2328-8957</identifier><identifier>DOI: 10.1093/ofid/ofx163.1041</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><subject>Abstracts</subject><ispartof>Open forum infectious diseases, 2017-10, Vol.4 (suppl_1), p.S415-S416</ispartof><rights>The Author 2017. Published by Oxford University Press on behalf of Infectious Diseases Society of America. 2017</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c2211-488c3376c87379e11947ec9c3315f8738f0846b86054c7caf43f3c1ab5133a3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5630753/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5630753/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,1604,27924,27925,53791,53793</link.rule.ids></links><search><creatorcontrib>Dropulic, Lesia</creatorcontrib><creatorcontrib>Wang, Kening</creatorcontrib><creatorcontrib>Oestreich, Makinna</creatorcontrib><creatorcontrib>Pietz, Harlan</creatorcontrib><creatorcontrib>Garabedian, Doreen</creatorcontrib><creatorcontrib>Jegaskanda, Sinthujan</creatorcontrib><creatorcontrib>Dowdell, Kennichi</creatorcontrib><creatorcontrib>Nguyen, Hanh</creatorcontrib><creatorcontrib>Laing, Kerry</creatorcontrib><creatorcontrib>Koelle, David</creatorcontrib><creatorcontrib>Azose, Aaron</creatorcontrib><creatorcontrib>Hunsberger, Sally</creatorcontrib><creatorcontrib>Lumbard, Keith</creatorcontrib><creatorcontrib>Chen, Aiying</creatorcontrib><creatorcontrib>Chang, Lee-Jah</creatorcontrib><creatorcontrib>Phogat, Sanjay</creatorcontrib><creatorcontrib>Cohen, Jeffrey</creatorcontrib><title>A Replication-Defective Herpes Simplex Virus (HSV)-2 Vaccine, HSV529, is Safe and Well-Tolerated in Adults with or without HSV Infection and Induces Significant HSV-2-Specific Antibody Responses in HSV Seronegative Individuals</title><title>Open forum infectious diseases</title><description>Abstract Background We conducted a phase 1, randomized, double-blind, placebo-controlled trial of a replication-defective HSV-2 vaccine, HSV529 (deleted for UL5 and UL29), in 60 healthy adults aged 18 to 40 years. Methods Subjects were enrolled in groups of 20 from 3 serogroups: HSV1+ or 
-/HSV2+ (group 1), HSV1+/HSV2– (group 2), and HSV1-/HSV2– (group 3). At months 0, 1, and 6, 15 subjects in each group received HSV529 intramuscularly and 5 subjects received placebo. The primary endpoint was the frequency of solicited injection site and systemic reactions from day 0 to 7 after each vaccination and unsolicited adverse events up to 6 months after the last dose. Results 89% of vaccine recipients experienced a mild to moderate solicited injection site reaction vs. 47% of placebo recipients (P = 0.006, 95% CI 0.129, 0.676) that did not preclude additional doses. 64% of vaccine recipients experienced solicited systemic reactions vs. 53% of placebo recipients (P = 0.44, 95% CI -0.179, 0.402). Two serious adverse events occurred in 2 participants and were assessed as unrelated to HSV529 administration. Serum neutralizing antibody titers significantly increased from baseline after 3 doses of HSV529 compared with placebo in group 3 only (P &lt; 0.001). This increase persisted up to 6 months after the third dose of vaccine (P &lt; 0.001). Serum and vaginal antibodies to HSV2 glycoprotein D (gD) also significantly increased after 3 doses of vaccine in group 3 subjects (P &lt; 0.001 and P = 0.012, respectively). The mean vaginal gD titer after 3 doses was about one-third of the mean serum gD titer. In addition, the vaccine induced significant levels of HSV2-specific antibody dependent cellular cytotoxicity (ADCC) after 3 doses in group 3 subjects compared with placebo (P &lt; 0.001). Vaccine-induced CD4 T-cell responses were detected in 46%, 27%, and 36% of subjects in groups 1, 2, and 3, respectively, one month after the third dose of vaccine. CD8 T-cell responses were detected in 8%, 18%, and 14% of subjects in groups 1, 2, and 3, respectively, at the same time point. Conclusion The HSV529 vaccine was safe, well-tolerated, and immunogenic, eliciting significant neutralizing, gD, and ADCC-mediating antibodies, and modest cellular immune responses in HSV seronegative individuals. NCT01915212 Disclosures L. Dropulic, sanofi pasteur: Collaborator, Research support; K. Wang, sanofi pasteur: Collaborator, Research support; M. Oestreich, sanofi pasteur: Collaborator, Research support; H. Pietz, sanofi pasteur: Collaborator, Research support; D. Garabedian, sanofi pasteur: Collaborator, Research support; K. Dowdell, sanofi pasteur: Collaborator, Research support; H. Nguyen, sanofi pasteur: Collaborator, Research support; K. Laing, sanofi pasteur: Research Contractor, payment for conducting T cell assays; D. Koelle, sanofi pasteur: Research Contractor, payment for conducting T cell assays; A. Azose, sanofi pasteur: Research Contractor, Payment for conducting T cell assays; A. Chen, sanofi pasteur: Employee, Salary; L. J. Chang, sanofi pasteur: Employee, Salary; S. 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Methods Subjects were enrolled in groups of 20 from 3 serogroups: HSV1+ or 
-/HSV2+ (group 1), HSV1+/HSV2– (group 2), and HSV1-/HSV2– (group 3). At months 0, 1, and 6, 15 subjects in each group received HSV529 intramuscularly and 5 subjects received placebo. The primary endpoint was the frequency of solicited injection site and systemic reactions from day 0 to 7 after each vaccination and unsolicited adverse events up to 6 months after the last dose. Results 89% of vaccine recipients experienced a mild to moderate solicited injection site reaction vs. 47% of placebo recipients (P = 0.006, 95% CI 0.129, 0.676) that did not preclude additional doses. 64% of vaccine recipients experienced solicited systemic reactions vs. 53% of placebo recipients (P = 0.44, 95% CI -0.179, 0.402). Two serious adverse events occurred in 2 participants and were assessed as unrelated to HSV529 administration. Serum neutralizing antibody titers significantly increased from baseline after 3 doses of HSV529 compared with placebo in group 3 only (P &lt; 0.001). This increase persisted up to 6 months after the third dose of vaccine (P &lt; 0.001). Serum and vaginal antibodies to HSV2 glycoprotein D (gD) also significantly increased after 3 doses of vaccine in group 3 subjects (P &lt; 0.001 and P = 0.012, respectively). The mean vaginal gD titer after 3 doses was about one-third of the mean serum gD titer. In addition, the vaccine induced significant levels of HSV2-specific antibody dependent cellular cytotoxicity (ADCC) after 3 doses in group 3 subjects compared with placebo (P &lt; 0.001). Vaccine-induced CD4 T-cell responses were detected in 46%, 27%, and 36% of subjects in groups 1, 2, and 3, respectively, one month after the third dose of vaccine. CD8 T-cell responses were detected in 8%, 18%, and 14% of subjects in groups 1, 2, and 3, respectively, at the same time point. Conclusion The HSV529 vaccine was safe, well-tolerated, and immunogenic, eliciting significant neutralizing, gD, and ADCC-mediating antibodies, and modest cellular immune responses in HSV seronegative individuals. NCT01915212 Disclosures L. Dropulic, sanofi pasteur: Collaborator, Research support; K. Wang, sanofi pasteur: Collaborator, Research support; M. Oestreich, sanofi pasteur: Collaborator, Research support; H. Pietz, sanofi pasteur: Collaborator, Research support; D. Garabedian, sanofi pasteur: Collaborator, Research support; K. Dowdell, sanofi pasteur: Collaborator, Research support; H. Nguyen, sanofi pasteur: Collaborator, Research support; K. Laing, sanofi pasteur: Research Contractor, payment for conducting T cell assays; D. Koelle, sanofi pasteur: Research Contractor, payment for conducting T cell assays; A. Azose, sanofi pasteur: Research Contractor, Payment for conducting T cell assays; A. Chen, sanofi pasteur: Employee, Salary; L. J. Chang, sanofi pasteur: Employee, Salary; S. Phogat, sanofi pasteur: Employee, Salary</abstract><cop>US</cop><pub>Oxford University Press</pub><doi>10.1093/ofid/ofx163.1041</doi><oa>free_for_read</oa></addata></record>
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title A Replication-Defective Herpes Simplex Virus (HSV)-2 Vaccine, HSV529, is Safe and Well-Tolerated in Adults with or without HSV Infection and Induces Significant HSV-2-Specific Antibody Responses in HSV Seronegative Individuals
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